NCT03796351

Pharmacodynamic and Safety of MT10107(Botulinum Type A Neurotoxin) in Comparison to BOTOX®

A Randomized, Double-blind, Intra-Individual Controlled, Single-Center, Phase 1 Healthy Volunteer Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Medy-Tox · Industry
• Sex: Male
• Age: 20 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This study design is a randomized, double-blind, intra-individual controlled, single-center, phase 1 healthy volunteer study. Subjects who voluntarily signed the informed consent and are judged to be eligible for this study will be intramuscularly injected with the study drug or the comparator at a randomized unit(2U, 5U, 10U, 20U, 30U) in each site of the Extensor digirotum brevis. Thereafter, follow-up visits will be made 14 days, 30days, 60days, 90days and pharmacodynamic and safety assessments will be conducted for total 90days.

Detailed description

This is a randomised, double-blind, intra-individual controlled, dose escalation study to assess the safety, tolerability and preliminary effectiveness of a single dose of MT10107 in comparison to Botox®50U (BOTOX® is a registered trademark owned by Allergan). This is the first-in-human study for MT10107, and will be performed in healthy volunteers. Subjects will be administered a single equivalent dose of MT10107 and Botox®50U by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose). The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	MT10107	Subjects will be administered a single equivalent dose of MT10107 and Botox® by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose). The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner.
DRUG	Botox	Subjects will be administered a single equivalent dose of MT10107 and Botox® by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose). The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner.

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2019-01-08
• Last updated: 2020-08-26

Locations

1 site across 1 country: South Korea